Status:
COMPLETED
Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor
Lead Sponsor:
Corcept Therapeutics
Conditions:
Drug Interaction Potentiation
Healthy
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mif...
Eligibility Criteria
Inclusion
- Be healthy
- Have a BMI of 18 to 32 kg/m2, inclusive and body weight more than 50 kg (110 pounds)
- Be judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings
- Have suitable veins for multiple venipuncture/cannulation
Exclusion
- Have multiple drug allergies, or be allergic to any of the components of mifepristone or itraconazole
- Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
- In the 1 year before study drug administration, have a history of drug or alcohol abuse
- In the 6 calendar months before study drug administration, on average
- Have smoked more than 5 cigarettes/day
- Have consumed more than 21 units of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)
- In 2 months prior to study drug administration, have donated/lost blood or plasma in excess of 400 mL
- In the 30 days before study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine
Key Trial Info
Start Date :
August 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03259542
Start Date
August 9 2017
End Date
December 11 2017
Last Update
February 22 2018
Active Locations (1)
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1
SeaView Research
Miami, Florida, United States, 33126